NCT00944359

Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7,680 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 6 Months – 27 Months
• Healthy volunteers: Accepted

Summary

Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea. The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.

Detailed description

This is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities. Communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. Within each intervention cluster, children will be randomly assigned to the intervention group at the household level. Children aged 6-27 months at enrollment will be eligible. The study duration is 12 months. The investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin A status.

Conditions

• Zinc Deficiency
• Diarrhea
• Malaria

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Daily preventive Zn; placebo treatment	7 mg zinc / day and placebo supplement during diarrhea episodes
DIETARY_SUPPLEMENT	Therapeutic Zn; daily placebo	20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
DIETARY_SUPPLEMENT	Intermittent Zn; placebo treatment	10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes
OTHER	Surveillance control group	Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-07-23
• Last updated: 2018-07-13

Locations

1 site across 1 country: Burkina Faso